The following data is part of a premarket notification filed by American Omni Medical, Inc. with the FDA for Air Vent Line Cat. No. Avl-36.
| Device ID | K875080 |
| 510k Number | K875080 |
| Device Name: | AIR VENT LINE CAT. NO. AVL-36 |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa, CA 92626 |
| Contact | George G Siposs |
| Correspondent | George G Siposs AMERICAN OMNI MEDICAL, INC. 2930-G GRACE LN. Costa Mesa, CA 92626 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-09 |
| Decision Date | 1988-02-29 |